Quarterly Newsletter:

December 2023

Issue #10

Editorial

As 2023 comes to a close, I've been pondering what our world would look like without immunisation. The 2019-2023 EU Mandate was marked by a succession of crises where vaccines were front and center, providing public health solutions. During the COVID-19 pandemic, scientific innovation and public-private partnerships were key to address the devastating social and economic costs. COVID-19 also brought to light many health-related gaps and challenges that must be addressed before the next inevitable pandemic - including the vulnerability of immunisation systems and gaps in European vaccination coverage data. 

In the next EU Mandate, several key ambitions must come to the forefront - first and foremost, securing Europe's position as a leader in vaccine innovation by enhancing the competitiveness of its R&D ecosystem. The EU has been a leader in vaccine R&D and manufacturing, hosting approximately 22% of global vaccine clinical trials over the past two decades. By January 2022, the EU had contributed to nearly 40% of the world’s COVID-19 vaccine exports. However, vaccine innovation in the EU is at risk due to limited funding, incentives and support for diverse vaccine types and platforms as well as complex clinical trial requirements and lengthy timelines. 

There must also be a strong emphasis on sustainable investment in immunisation. The Health Emergency Preparedness and Response Authority (HERA) is a step in the right direction toward this pursuit. Investing in immunisation pays-off: it contributes to economic growth by keeping population productive and preventing disruption of healthcare systems. Moving forward, the EU must also put in place an EU Immunisation Strategy that fosters innovation and strengthens protection against vaccine-preventable diseases throughout the life course. This will lead us toward a healthier, innovative and more prosperous Europe. 

To support evidence based decision making, the next EU Mandate must put a particular focus on integrating data and digital technologies into the core of healthcare delivery. A recent OECD report confirmed that during the pandemic, digital health helped to develop vaccines, evaluate their efficacy, monitor their deployment, and support a portable proof of vaccination. We must now build on this, supporting the generation and use of real-world data in the EU and developing surveillance systems to monitor the impact of both new and established vaccines.

As we work to tackle current challenges within the vaccine ecosystem in the EU, prioritising an EU Immunisation Strategy, and integrating data-driven technologies will be imperative steps. Immunisation solutions – both current critical vaccines and future innovations – are at the centre of Europe’s strategic autonomy and health security. These ambitions can collectively pave the way for a forward-looking approach to protect our societies and economies, and advance Europe’s leadership to tackle continuously evolving health challenges.

Vaccines Europe External Engagement

Events we participated in

• Life Course Immunisation Summit – event by CLCI (Spain), 22-24 November  

• ESCAIDE - event by ESCAIDE (Barcelona & Online), 22-24 November

• ISPOR Europe 2023 - event by ISPOR (Copenhagen), 12-15 November 

• Vaccination and Public Health Challenges and Perspectives - event by Ygeiamou (Athens), 9 November

Stakeholder meetings

• Second bilateral meeting between EMA and Vaccines Europe - event by EMA (Amsterdam), 27 November

• Seventh Industry Standing Group (ISG) meeting - event by EMA, 23 November

• Joint Industrial Cooperation Forum (JICF) - 22 November

Public Consultations

Vaccines Europe's official response to revisions of the General Pharmaceutical Legislation (GPL)

Vaccine innovation is happening at a level not seen before. With a promising pipeline aimed at tackling current and future health challenges, the EU pharmaceutical legislation must be an enabler rather than a roadblock to this innovation. Vaccines have their own complexities that cannot be undertaken in a one size fits all proposal.  Therefore, a holistic approach from prevention to care is needed to ensure that this promising industry – representing a valuable asset for the EU, healthcare systems, the economy and society as a whole – is not forgotten

Communications Highlights

New Joiner! 

We are pleased to welcome Charlotte Vernhes to the Vaccines Europe team as our new Director of Scientific and Medical Affairs! 

Charlotte brings a wealth of knowledge and experience following her role at Sanofi as the Head of Vaccines R&D partnerships and stakeholder engagement for Europe. Her leadership in impactful initiatives such as the PROMISE Project and RESCEU IMI consortiums and her work on machine learning models for biomarker discovery make her a valuable addition to the team.  

2023 Pipeline Review 

On 1 December, Vaccines Europe published the 2nd edition of our Pipeline Review, showcasing the pipeline of our members until August 2023. 

This edition highlights the constant engagement of the vaccine industry to address population needs despite the challenges faced by vaccine manufacturers across various development stages. This year's review brings to light 3 trends:

• There is an increasing number of combination vaccines against respiratory diseases (e.g. COVID-19, influenza and RSV). 
• The recognition of vaccination as an indispensable tool in the fight against AMR is also reflected in the pipeline of Vaccines Europe members, with 15 candidates targeting antibiotic-resistant bacteria on the WHO’s Priority Pathogens list and many more preventing viral infections.
• The report showcases a wide variety of platform technologies used to develop vaccines, which allows for tailored solutions to combat different pathogens.

AMR campaign 

On 16 November, we launched our AMR campaign ahead of European Antibiotics Awareness Day (EAAD) and World AMR Awareness Week (WAAW). Supported by the release of a white paper and an interview between our Executive Director Sibilia Quilici and Politico, the campaign garnered a top spot in the Politico Morning Healthcare newsletter. 

The white paper spotlights the role of vaccination as a valuable tool to address AMR, working in tandem with antibiotics by preserving their value, increasing their longevity and ensuring their continued effectiveness to protect public health. As such, Vaccines Europe outlines several strategies to enhance the coverage of existing vaccines and support the development of vaccines in the pipeline.

EU Elections Campaign

Last month, Vaccines Europe met with key stakeholders at the European Parliament, calling on all European parties to embrace a robust EU Immunisation Strategy aimed at protecting people at all ages and stages of life toward the goal of an innovative, healthy and prosperous Europe. The event was kicked off with a panel discussion between our Executive Director Sibilia Quilici, President Florence Baron-Papillon, Illaria Passarani of the PGEU, and MEP Nicolas Gonzalez Casares. 

EU Flu Day 

In October, around 100 people gathered in person and online to participate in the 2023 EU Flu Day event at the European Parliament. Kindly hosted by MEP István Ujhelyi (S&D, Hungary), as well as with the participation of MEP Dolors Montserrat (EPP, Spain), the event brought together healthcare players and policymakers to discuss how to increase flu vaccination uptake and better protect people in Europe from seasonal influenza.

Empowering health choices in the EU   

In October as part of our EU Attractiveness campaign, Chantal Friebertshaeuser, Senior Vice President & GM, Europe, Middle East, Australia, and Canada (EMEAC) at Moderna, explained how the EU can help foster an environment that supports vaccine diversity toward a healthier Europe. Choice equals access as different vaccines vary in effectiveness, storage requirements, and dosing regimens. When a variety of vaccines are available, healthcare professionals and individuals have options to protect themselves effectively. 

During the COVID-19 pandemic, the value of vaccination was spotlighted like never before, with scientists, policymakers and citizens working together to protect each other’s health. Now, as we enter into a post-pandemic world, troubling vaccination rates are resurfacing. Human papillomavirus (HPV) vaccination is an example of this, with coverage dropping around the world.

In light of this, France has taken a crucial step toward safeguarding the health of its future generations. In October, the country launched a vaccination campaign against HPV for school students aged 12. To increase low rates of vaccination among students - and boys in particular, the campaign aims to vaccinate 80% of those between 11 and 19 years old by 2030. The significance of this vaccination campaign lies in its potential to prevent cancers that stem from HPV infections. In France, there are over 6 000 new cases of HPV related cancers annually.

This strategic response underscores the power of health data as a crucial public health tool for informed decision-making. With the knowledge that HPV vaccination rates were low and slowed down by the COVID pandemic in 2020 and 2021 in France, the country was able to respond with a large-scale vaccination campaign. In particular the French public authorities identified strong inequalities in terms of uptake throughout the country and this new campaign is designed to tackle this specific issue. Robust data collection makes it possible to assess the effectiveness and impact of vaccination programmes, estimate vaccine coverage rates, identify any gaps or disparities in vaccine uptake and evaluate long-term benefits. Overall, real world data allows for actionable insights to guide policy making towards better protection against vaccine-preventable infection related cancers, such as HPV.

In the wake of sub-optimal vaccination rates, France's campaign stands as a vital step toward securing the health of future generations, highlighting the pivotal role of data-driven decisions in combating preventable infections and safeguarding against HPV-related cancers.

Key Figures

2020/2021 ECDC Flu Vaccination Coverage Rates (VCRs)

Health Policy Highlights

EU Commission outlines future actions on medicine shortages

The European Commission has published a Communication outlining future actions to prevent and manage medicine shortages. In the short term, the Commission will set up a new voluntary solidarity mechanism between Member States. This will enable a Member State to request medicines from other EU countries that have sufficient supply.

The Communication also include a series of actions to ensure security of supply in the longer term. These include anticipating national and EU action on shortages foreseen in the pharmaceutical reform, the publication of an EU List of Critical Medicines, the creation of a multi-stakeholder Critical Medicines Alliance in early 2024 and the setting up of strategic partnerships with third countries to produce critical medicines.

Other possible measures could include public procurement (possibly based on Commission guidance and common criteria), medium-term contractual incentives, capacity reservation contracts and the diversification of global supply chains. The Commission also wants to develop with Member States a common strategic approach to stockpiling and foster the workforce needed for a stronger pharmaceutical sector.

Specific actions are also planned on vaccines. As part of preventative actions to maintain the availability of antibiotics in 2023-2024, the Commission plans to conduct targeted joint procurement, or procurement on Member States’ behalf, of vaccines and therapeutics for respiratory syncytial virus (RSV). In doing so it hopes to prevent aggravation of shortages due to increased demand for antibiotics to treat co-infections between RSV and bacteria. More generally, the Commission pledges to continue to finance research on vaccines and engage in Team Europe international initiatives to support vaccine access and manufacturing in Africa and Latin America.

The Communication emphasises the importance of harmonising data and monitoring shortages. This will take shape via the European Shortages Monitoring Platform, which will report information on available stocks and shortages. The Platform is expected to become operational as from 2025.

Pharma reform: MEPs work to develop Parliament’s final text by March 2024

The European Union’s review of the General Pharmaceutical Legislation is marching forward. In October, lead rapporteurs MEPs Pernille Weiss (EPP, DK) and Tiemo Wölken (S&D, DE) presented their reports on the Directive and the Regulation proposing amendments to the European Commission’s drafts. MEPs from the Environment, Public Health and Food Safety Committee (ENVI) have since submitted over 3,000 amendments to the two files, with a particular focus on incentives, access and Unmet Medical Need (UMN).

Political groups are far apart on some topics. MEPs have made amendments to various proposals such as the duration of Regulatory Data Protection (RDP). Several MEPs have deleted the linkage of extended RDP with the obligation to launch in all 27 EU Member States, replacing it with the obligation to file for pricing and reimbursement within 2 years of market authorisation. If the product is a vaccine, Member States will also need to include it in their national immunisation programmes. There are also different proposals for the definition of vaccines, with amendments suggesting to either narrow the new definition to remove treatment vaccines from the scope or to broaden the definition to explicitly refer to antigens.

On other issues, such as UMN, there seems to be more alignment – with the major political groups being in favour of broader criteria than those proposed by the European Commission. A final vote in the ENVI Committee is expected on 7 March, with the aim of a vote of the whole Parliament in Plenary on 10-11 April. On the side of the Council, Belgium will initiate negotiations on the topic of shortages and UNM.

Belgian Presidency to tackle AMR, unmet needs and vaccine-preventable cancers

Belgium has presented the priorities for its Presidency of the Council of the EU in the first half of 2024 under the title “A Europe that cares, prepares and protects”. The Belgian Presidency will aim to strengthen the European Health Union through a variety of actions and events.

Aiming to shift towards a “needs-driven system” for healthcare, Belgium will propose a common methodology to identify and assess unmet needs. For the EU to be better prepared on health, Belgium also wants to expand the EU’s capacity to conduct large-scale clinical trials, citing the lack of utility of most clinical trials for COVID-19 treatments, and to advance the discussion on antimicrobial resistance (AMR).

The country will also advance the negotiations for a Council Recommendation on vaccine-preventable cancers. The Commission is expected to present its proposal for the Council Recommendation at the beginning of next year, notably including suggestions for Member States to boost uptake of vaccines for HPV and hepatitis B, and to set up an HPV taskforce.

Belgium has indicated that the European Commission’s Communication on medicine shortages will be implemented during its Presidency, including the creation of a Critical Medicines Alliance in anticipation of a potential Critical Medicines Act in the next mandate. While several Member States are already applying new stockpiling obligations ahead of winter to support the solidarity mechanism, Belgium has called on all of them to ensure the usability of the mechanism given the interconnection of EU medicine markets.

In terms of the broader legislative agenda, the Belgian Presidency will advance negotiations on the General Pharmaceutical Legislation, with an initial focus on finalising negotiations on the provisions on medicines shortages and then on incentives. It will also aim to conclude the trilogue negotiations with the Parliament on the European Health Data Space (EHDS), substances of human origin (SoHO) and the fees of the European Medicines Agency (EMA). Upcoming meetings of EU health ministers in EPSCO are planned for 22-23 April and 16 June 2024.

Medicines regulators release first electronic product information

European medicines regulators have published the first common EU electronic product information (ePI) for human medicines. The published ePIs are for medicines evaluated by the EMA or by national authorities in Denmark, the Netherlands, Spain and Sweden. The ePIs are being created and tested through a one-year pilot initiative by the Heads of Medicines Agencies (HMA), EMA and the Commission to enable the transition to the electronic system for medicines both nationally and at European level.

The ePIs can be viewed on the Product Lifecycle Management Portal in English for centrally approved medicines and in the local language for nationally approved ones. Testing is ongoing to enable access to ePIs in all EU languages. The ePI data can also be accessed via a public application programming interface where developers can explore the use of this new format within existing digital platforms.

EU4Health to fund activities on vaccines, cancer and AMR in 2024

The European Commission has released EU4Health’s work programme for 2024 with a budget of over 750 million euros. The work programme finances a wide array of actions on health, including on mental health, global health, digital health, cancer screening and the EU’s capacity to produce medicines and innovate the manufacturing of critical medicines and ingredients. Over 470 million euros have been earmarked for HERA and almost 118 million euros for activities on cancer.

To strengthen Europe’s preparedness and response capacities, HERA will be provided funds to create a European Hub for vaccine development and work on innovation of next-generation respiratory protection and the development of novel antivirals. HERA will also conduct procurement activities for ever-warm facilities for vaccine production under EU FAB.

On cancer, 20 million euros is earmarked for a joint action with Member States on cancers caused by infections and vaccine-preventable cancers, notably tackling HPV, hepatitis B and hepatitis C. This joint action may also address HIV/AIDS, tuberculosis and viral hepatitis. Five million euros will be provided for health literacy for cancer prevention and care. EU4Health will also finance health-related activities of international organisations. The OECD will be provided funds to work on health promotion and disease prevention, focused on non-communicable diseases as well as cancers caused by infections and vaccine-preventable cancers.

EU4Health has several actions planned on fighting AMR. HERA’s work on AMR will focus on innovation, supply capacities and access. The WHO will be provided funds to support the development of antibiotics to strengthen global preparedness and response, as well as to work on AMR and healthcare-associated infections. The OECD will receive funds to work on AMR action and projections.

What We Are Reading, Attending & Watching

The Socio-economic value of adult immunisation - A report by the OHE, commissioned by IFPMA

HERA Conference - An event by the Health Emergency Preparedness and Response (HERA) department on 5 December, 2023

Health at a Glance 2023 - a report by the OECD

People-centred approach to addressing antimicrobial resistance in human health - a publication by the WHO

Seasonal influenza vaccination recommendations and coverage rates in EU/EEA Member States - a report by the ECDC